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Prospectieve studie over aortaklep keuze.


- candidate number13334
- NTR NumberNTR3618
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2012
- Secondary IDs2012-323 MEC ErasmusMC
- Public TitleProspectieve studie over aortaklep keuze.
- Scientific TitlePatient’s experience with decision-making in prosthetic aortic valve selection.
- ACRONYMDecision Making AV
- hypothesisFor patients with severe symptomatic aortic valve disease, aortic valve replacement surgery is the treatment of choice. Two options exist: Mechanical and bioprosthetic aortic valve. The decision which valve type to choose is difficult, since in most patients survival is comparable with either valve substitute but the nature of prosthetic valve-related morbidity differs significantly. While mechanical valve recipients are faced with an increased hazard of thrombo-embolic and bleeding complications, bioprosthetic valve recipients have an increased hazard of a reoperation later in life, since biological valves have a limited durability. Clinical characteristics like age, life expectancy, indication/contraindication for anticoagulation, and comorbidities play an important role in the decision-making process. However, patient preferences should also play a major role in the decision-making, since the nature of valve-related morbidity for the different prosthetic valve options is hard to compare and may be value-sensitive. Consideration of informed patient preferences, the use of decision aids and the process of ‘shared decision making’ get more and more attention in healthcare, and may improve the decision making process and hopefully lead to better patient outcomes.
One problem is that shared decision making remains undefined. First step to investigate and improve shared decision making in aortic valve replacement is to assess how patients who require aortic valve replacement experience the current decision making process.
- Healt Condition(s) or Problem(s) studiedSevere symptomatic aortic valve disease
- Inclusion criteriaAdult (18 years or older) patients who have been accepted for aortic valve replacement in Erasmus University Medical Center (Erasmus MC), University Medical Center Utrecht (UMCU) and Leiden University Medical Center (LUMC).
- Exclusion criteriaPatients who are legally incapable.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 25-sep-2012
- planned closingdate31-mrt-2013
- Target number of participants150
- InterventionsDesign and perform two surveys among elective adult patients who have been accepted for aortic valve replacement in Erasmus University Medical Center (Erasmus MC), University Medical Center Utrecht (UMCU) and Leiden University Medical Center (LUMC).

Survey 1 will be conducted after the decision for aortic valve replacement has been made, but before the operation.

Survey 2 will be conducted 3 months after the operation.
- Primary outcomeTo explore among adult patients who have been accepted for aortic valve replacement, patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on patient participation in decision making, uncertainty in choosing options, how patients value the importance of the individual risks and benefits associated with the different therapeutic options, and patient preference for presentation of scientific evidence in relation to their numeracy.
- Secondary outcomeTo assess in the same patient population 3 months post-surgery patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on participation in decision making, uncertainty in choosing options, valve specific quality of life, and patient satisfaction with the decision that was made.
- TimepointsApril 2012:
1. Writing research proposal;
2. Study relevant literature;
3. Design surveys.
May 2012:
1. METC proposal preparation;
2. Study relevant literature.
June/July 2012:
1. Perform survey.
August/Sept. 2012:
1. Perform survey.
October 2012:
1. Perform survey &Data entry.
November 2012:
1. Perform survey &Data entry.
December 2012 Perform survey January/February 2013:
1. Data-analysis NIHES.
March 2013:
1. Write paper & Defend thesis.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Nelleke M. Korteland
- CONTACT for SCIENTIFIC QUERIES Nelleke M. Korteland
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryTo explore among adult patients who have been accepted for aortic valve replacement, patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on patient participation in decision making, uncertainty in choosing options, how patients value the importance of the individual risks and benefits associated with the different therapeutic options, and patient preference for presentation of scientific evidence in relation to their numeracy.
To assess in the same patient population 3 months post-surgery patient knowledge of the advantages and disadvantages of different valve prostheses and the information that patients received, patient view on participation in decision making, uncertainty in choosing options, valve specific quality of life, and patient satisfaction with the decision that was made.
- Main changes (audit trail)
- RECORD19-sep-2012 - 27-sep-2012


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